Senior Quality Engineer

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

In this role, you will work with a team on activities that focus on implementing and optimizing quality engineering practices related to Complaints Investigation, Post Market Surveillance and Risk Management while ensuring a culture of quality and compliance with global regulatory requirements.

• Investigate complex product quality and compliance issues (e.g. Product Risk Assessment, CAPAs, non-conformances, audit observations) based on engineering principles; analyze results, make recommendations and develop reports.
• Execute timely complaint investigations utilizing a multifunctional approach and ensuring issues are addressed in a systematic, methodical manner. Ensure investigations are adequate and comply with applicable procedures.
• Lead post-market surveillance activities to monitor safety, performance and effectiveness of products. Assess benefit-risk determination of devices throughout their entire life cycle. Complete review of post-market data and post market reporting activities (Eg. PSUR/PMSR) as required.
• Execute risk management activities through-out the post-market phase and ensure compliance with regulatory requirements. Support, update, and maintain technical content of risk management files and ensure integration with other aspects of the quality system.
• Other incidental duties assigned by Leadership

• Bachelor’s degree in Engineering or a related field and a minimum of 4 years of relevant industry experience, OR
• Master’s degree in Engineering or a related field and a minimum of 3 years of relevant industry experience, OR
• Ph.D. in Engineering or a related field (no prior experience required), OR
• An equivalent combination of education and experience as defined by Edwards criteria.

• Proven expertise in usage of MS Office Suite; CAD experience preferred
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Working knowledge and understanding of statistical techniques will be required for work related plant sites
• Previous experience working with lab/industrial equipment required
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.